Prostate Cancer Metastatic
Conditions
Keywords
mCRPC, Lu-PSMA, Prostate Cancer, Radioligand Therapy
Brief summary
This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.
Interventions
DIAGNOSTIC_TESTBlood draw for ctDNA and circulating tumor cell collection.
During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells.
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants should be at least 18 years old. * Participants should be able to understand the written information and be able to provide informed consent. * Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.
Exclusion criteria
None applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 44 months | Overall survival will be defined as the time from inclusion to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 44 months | Progression free survival will be defined as clinical, radiological or PSA progression according to Prostate Cancer Working Group 3 (PCWG3) or death, whichever occurs first. |
| Heterogeneity of PSMA-positivity | 44 months | Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA. |
| Effect of CTC PSMA expression on response to treatment. | 44 months | Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment. |
| Effect of biomarkers in blood on response to treatment. | 44 months | Exploring the association between biomarkers in blood and response to treatment |
| PSMA-PET scan data and response to treatment. | 44 months | Exploring associations between PSMA-PET and therapy scans and response to treatment. |
Countries
Netherlands
Contacts
Primary ContactStijn Koolen, PhD
Outcome results
None listed